BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-508UC EA INSULIN CH EN US

    MDR report key: 1133363 · Received August 22, 2008

    Report

    Report Number
    2032227-2008-01432
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    August 10, 2008
    Report Date
    August 11, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K990801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 727 MG/DL. NURSE STATED THAT SHE BELIEVES THE EVENT WAS NOT A PUMP ISSUE AND THE CUSTOMER DOES NOT COMPLY WITH THE INSULIN PUMP THERAPY. IT WAS STATED THAT THE BOLUS HISTORY REVEALED THREE BOLUSES FROM LATE FRIDAY UNTIL SUNDAY MORNING. IT WAS ALSO STATED THAT THE CUSTOMER WEARS THE INFUSION SET UP TO ONE WEEK. TROUBLESHOOTING WAS NOT PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-508UC EA INSULIN CH EN US INFUSION PUMP LZG MEDTRONIC MINIMED MMT-508UC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization